FDA-Device2020-06-10Class II
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-de
Philips North America, LLC
Hazard
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Sold states
US Nationwide distribution.
Affected count
2360 Units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2020Don't want to check this manually?
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